EP2298192B1 - Catheter with balloon - Google Patents

Catheter with balloon Download PDF

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Publication number
EP2298192B1
EP2298192B1 EP10169255A EP10169255A EP2298192B1 EP 2298192 B1 EP2298192 B1 EP 2298192B1 EP 10169255 A EP10169255 A EP 10169255A EP 10169255 A EP10169255 A EP 10169255A EP 2298192 B1 EP2298192 B1 EP 2298192B1
Authority
EP
European Patent Office
Prior art keywords
balloon
catheter
shaft
expandable element
debris
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP10169255A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2298192A1 (en
Inventor
Eran Hirszowicz
Orit Hirszowicz
Yoav Turgeman
Omri Mairon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Angioslide Ltd
Original Assignee
Angioslide Ltd
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Filing date
Publication date
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Publication of EP2298192A1 publication Critical patent/EP2298192A1/en
Application granted granted Critical
Publication of EP2298192B1 publication Critical patent/EP2298192B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3435—Cannulas using everted sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A61F2002/9586—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve the means being inside the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present invention relates to invasive medical devices, and more specifically to such devices for the delivery and retrieval of objects in the body.
  • Catheters are medical devices that are used to deliver or retrieve objects in the body.
  • the catheter tip is inserted into the body through a natural or artificial opening and delivered to a desired location.
  • a catheter is used to deliver and deploy a stent in an arterial stenosis.
  • Endoscopic catheters are used to deliver an imaging device for gastrointestinal use.
  • U.S. Patent 5,437,638 to Bowman discloses a multilumen catheter having a plurality of inflatable tubes at its tip. Each tube is attached to a different lumen, so that each tube may be individually inflated and deflated. The tubes are initially inserted into their respective lumens. In a procedure to open a constricted body passage, the tubes are inflated in the constriction. The tubes may also be provided with gripping surfaces and are manipulated by appropriate fluid pressures to grasp and recover objects in a body passageway.
  • U.S. Patent No. 5,941,895 to Myler et al discloses a catheter for the retrieval of a stent.
  • the catheter includes a tubular body and an axially moveable guidewire that are adapted to grasp engagement members on a stent to be retrieved.
  • U.S. Patent No. 5,109,830 to Cho discloses a catheter having a tip designed to facilitate navigation of the catheter through the cardiovascular system.
  • the tip has an inner element having a memorized preformed curved shape that it assumes when it is not disposed within an outer restraining sleeve.
  • the inner element When in the sleeve, the inner element is straightened by the rigidity of the sleeve.
  • the inner element is removed from the sleeve in order to facilitate navigation of the tip around a curve or bend in a blood vessel.
  • the inner element is disposed in the sleeve when passing through a straight region of a blood vessel.
  • U.S. Patent No. 4,597,389 to Wheat discloses a catheter having an annular balloon at its tip for grasping an object
  • the catheter tip is delivered to the object to be grasped with the balloon in its deflated state.
  • the balloon is then positioned with the, object in the central passageway of the annular balloon.
  • the central passageway becomes constricted so as to grasp the object
  • the catheter is then withdrawn from the body.
  • US 4,469,100 diseloses a system according to the preamble of claim 1, an extraction device for removing foreign bodies such as a uretal stone from a human body passage.
  • a double lumen catheter is provided having a tubular balloon attached circumjacent o the distal end thereof.
  • a suction lumen is open at the distal end and a pressure applying lumen is open to the interior of the balloon.
  • the balloon includes a lower reentrant portion.
  • the present invention is defined in the appended claims and provides a system comprising a catheter and an expandable element.
  • the expandable element may be for example, an inflatable balloon. In its expanded state, the expandable element has an annular shape surrounding a central passageway.
  • the expandable element is configured to roll on the catheter shaft without slipping when at least a portion of the shaft is in the passageway.
  • the expandable element is mounted on the catheter shaft and is delivered to a body site in an unexpanded state. The expandable element is then brought to the expanded state.
  • the catheter may be used to deliver or retrieve an object into or from a body passageway.
  • the catheter may also be used to retrieve atheromatous plaque debris and other particulate, solid or semi-solid matter present in pathologically-involved blood vessels, and to remove said matter from the body
  • the system may also be used to assist in navigating the catheter tip in narrow or curved body passages.
  • the invention provides a system comprising:
  • the system of the invention can be used in a method for delivering an object to a site in the body, comprising:
  • the system of the invention can be used in a method for retrieving an object from a body site comprising:
  • the System of the invention can be used in a method for removing debris and/or other particulate matter from a blood vessel comprising:
  • the system of the invention can be used in a method for distending and/or expanding a pathologically-involved region of a blood vessel wall and removing debris and/or other particulate matter from said blood vessel comprising:
  • the system of the invention can be used in a method for distending and/or expanding a pathologically-involved region of a blood vessel wall and removing debris and/or other particulate matter from said blood vessel comprising:
  • the system of the invention can comprise a balloon bearing a sleeve on its outer surface, therein a portion of the inner surface of the wall of said sleeve is attached at one or more attachment points to the outer surface of said balloon, such that an annular space exists between said sleeve and at least a portion of the outer surface of said balloon on at least one side ofsaid attachment points.
  • Fig. 1 shows a catheter 10 .
  • the catheter 10 has a cylindrical shaft 12 extending from its proximal end 14 to its distal end 16.
  • the cylindrical shaft 12 may have a single lumen 13, as shown in Fig. 1 , or it may have two or more lumens (not shown).
  • At the distal end 16 is an expandable element 18.
  • the expandable element 18 may be an inflatable balloon 18, as shown in Fig. 1 .
  • the expandable element may be resiliently compressible element that is maintained in a compressed state by means of a restraining sleeve that is removed in order to allow the element to attain its expanded state.
  • the expandable element may be a recovery coil, a self-expendable element, or an element formed from a shape-memory material or other means.
  • the balloon 18 is shown in Fig. 1 in its deflated state. In this state the balloon is a cylindrical shell formed from an inner layer 20 and an outer layer 21.
  • the inner and outer layers 20 and 21 are formed from a biocompatible flexible fluid impervious material.
  • Materials for the manufacture of balloons for use in invasive medical devices include polyolefines (such as polyethylene, polypropylene and polypentene), polyesters (such as Mylar), polyurethane, polyamides (nylons), polyamines, polyvinyls (such as flexible polyvinylchloride, or PVA), liquid crystal polymers, styrene polymers (such as ABS) and other polymers such as silicone, latex, thermoplastic elastomers, polyethylene terephthalates, polyacrylenesulfide, polycarbonate, polysulfone, polyimide, polyeterimide, Peek; as well as copolymers, poly-blends and transformed species (e.g. following irradiation, cross linking or chemical treatment) of the aforementioned materials or of other materials, providing they have the appropriate biomechanical properties.
  • polyolefines such as polyethylene, polypropylene and polypentene
  • polyesters such as Mylar
  • polyurethane such as polyamide
  • the inner and outer layers 20 and 21 are continuous with each other.
  • the inner and outer layers 20 and 21 may be welded together at circular seams 22.
  • the balloon thus has an annular lumen 24.
  • the lumen 24 is collapsed when the balloon 18 is in its deflated state shown in Fig.1 .
  • the lumen 24 is in fluid communication with the lumen of the catheter shaft through an opening 26 in the wall of the shaft, and an overlying opening 28 in the inner layer 20.
  • the balloon having an annular lumen (as described hereinabove) is attached to the catheter shaft at one or more points on the inner circumference of the balloon. At one or more of these attachment points there is an opening in the balloon that is situated such that it overlays a similarly-sized and shaped opening in the shaft wall, thereby permitting the passage of an inflation medium between the lumen of the catheter shaft and the internal space of the balloon.
  • the number of attachment points is not limited and these points can be arranged in any suitable or convenient arrangement, for example including (but not limited to) longitudinal, circumferential, helical or other arrangements.
  • the inner layer 20 is attached to the outer surface of the catheter shaft 12 at two discrete attachment regions 64 and 66.
  • the inner layer 20 is bonded to the catheter shaft in a single circular band 32 around the shaft 12 that surrounds catheter opening 26 and balloon opening 28.
  • the balloon inner layer 20 is attached to the catheter shaft (either at two discrete regions or as a single circular band, as described in the two immediately preceding preferred embodiments and shown in Figs. 7a and 7b ) as close as possible to the margins of shaft opening 26, such that, in the case of the embodiment depicted in Fig.
  • the distance between the distal side of attachment region 64 and the proximal side of attachment region 66 approximates to the diameter of opening 26.
  • the width of said circular band i.e. the distance between the proximal and distal margins of said band
  • the bonding of the balloon to the catheter shaft at the attachment site(s) may be achieved by the use of any suitable biocompatible adhesive, heat welding, ultrasonic welding, or mechanical means.
  • the balloon 18 is inflated by delivering a fluid such as compressed air, carbon dioxide, contrast media or water from a source 30 through the lumen 13 of the catheter shaft to the lumen of the balloon 18.
  • a fluid such as compressed air, carbon dioxide, contrast media or water
  • Fig. 2 shows the catheter after inflation of the balloon 18.
  • the balloon 18 surrounds a central passageway 25 which is at least partially occupied by the catheter shaft 12. Since the wall of the balloon is bonded to the catheter shaft only at the seam 32, the balloon can travel along the shaft between a first position shown in Fig. 2a in which it extends maximally in a posterior direction, and a second position shown in Fig. 2b in which it extends maximally in an anterior direction. Movement of the balloon between the positions shown in Fig. 2 occurs by the balloon 18 rolling along the shaft 12 without slipping, with the outer surface 21 of the balloon 18 passing over the inner surface 20.
  • the balloon 18 may be attached to the catheter shaft close to the distal end of catheter shaft 12, such that when said the balloon is caused to roll over said shaft in a distal direction, said balloon may occupy an extreme distal position, such that at least a portion thereof extends beyond the distal tip of said catheter shaft.
  • balloon 18 is attached to the shaft at a location such that upon rolling, no portion of said balloon ever extends beyond the distal tip of catheter shaft 12.
  • the balloon and catheter are mutually arranged such that a length of catheter shaft always extends beyond the distal margin of said balloon.
  • Fig. 1 the terminal balloon location depicted in Fig. 1 may result in collapse of the portion of the balloon that extends beyond the distal tip of the catheter, thereby releasing any objects, debris or other substances or entities held by that region of the balloon. Consequently, the presently described embodiment (having the balloon located in a more central position) would be the embodiment of choice for such balloon geometries and materials.
  • the balloon position in this embodiment is schematically shown in Figs. 7 and 9 .
  • the catheter system of the present invention may, in one mode of operation, be used to retrieve atheromatous plaque debris and other particulate, solid or semi-solid matter present in pathologically-involved blood vessels, and to remove said matter from the body. Furthermore, in a modification of this mode of operation (as will be described hereinbelow), the catheter system of the present invention may also be used to distend and/or expand a pathologically-involved region of a blood vessel wall (e.g. in a region of the internal vessel wall in which there has been a build up of atheromatous plaque), in addition to safely retrieving any plaque debris released by this process.
  • a pathologically-involved region of a blood vessel wall e.g. in a region of the internal vessel wall in which there has been a build up of atheromatous plaque
  • Such debris (and, indeed, any other particulate or semi-solid matter present in the region of the catheter balloon) is retrieved by means of 'trapping' said debris in the space between the balloon wall and the catheter shaft.
  • said debris In the case of debris trapped beneath the distal portion of the balloon, said debris is held in position during proximal movement of the catheter by a syringe-like suction effect (i.e. the creation of a reduced pressure zone within the blood vessel on the distal side of the proximally-moving inflated balloon).
  • a syringe-like suction effect i.e. the creation of a reduced pressure zone within the blood vessel on the distal side of the proximally-moving inflated balloon.
  • said debris Conversely, in the case of debris trapped beneath the proximal portion of the balloon, said debris is held in position during movement of the catheter by the distally-directed hydrodynamic forces exerted by the arterial blood flow.
  • the entrapment process is completed following deflation of the balloon (or other expandable element), as a result of which the debris is securely held between the balloon and catheter shaft, thus allowing the safe withdrawal of the catheter system through the vasculature and the removal of said system from the body.
  • the catheter shaft further comprises surface features that may assist in the retention of atherosclerotic plaque debris and other solid, semi-solid particulate or aggregate material on the surface of said shaft.
  • the debris which is trapped in the annular space between the inflated balloon and the catheter shaft may be retained and subsequently removed from the body upon withdrawal of the catheter.
  • Fig. 8 depicts three possible, but not limiting conformations for the retention elements. Firstly ( Fig. 8a ), the elements may be in the form of collection cups 68 that encircle the catheter shaft.
  • the retention element is provided in the form of a series of grooves 70, of any shape and profile, radial or axial to the catheter shaft or forming any angle with the catheter shaft.
  • Fig. 8b the retention element is provided in the form of a series of grooves 70, of any shape and profile, radial or axial to the catheter shaft or forming any angle with the catheter shaft.
  • the retention element is present in the form of a series of surface protrusions arranged such that there is a debris-retaining annular groove or depression 72 between each adjacent pair of protrusions 74, of any shape and profile, radial or axial to the catheter shaft or forming any angle with the catheter shaft.
  • the retention elements may be formed of any combination of the aforementioned grooves and protrusions.
  • the aforementioned retention elements may be located on the catheter shaft 12 surface either on the distal side of the balloon 18 ( Fig. 9a ), on the proximal side of said balloon ( Fig. 9b ) or on both sides thereof ( Fig. 9c ).
  • the three aforementioned examples of retention elements should not, however, be considered as limiting. Rather, any suitable element that may be conveniently formed within the wall of the catheter shaft, or added thereto may be employed in order to increase the retention of debris by the presently-claimed catheter system.
  • the presently-disclosed and claimed system further comprises a retaining sleeve for assisting in the collection of debris (and other particulate matter, as mentioned hereinabove) and for the storage thereof prior to, and during, the removal of the catheter from the body.
  • Said debris is collected and stored in the space between the sleeve and a portion of the catheter shaft not occupied by the balloon.
  • said sleeve functions as an 'extension' of the balloon with respect to its debris-trapping capability.
  • the debris may be trapped and stored between at least one portion of the sleeve and the balloon.
  • the sleeve which is attached to the outer surface of the balloon, can - in one embodiment - cover only part of the length of said balloon.
  • the sleeve may be of the same length as the balloon and arranged such that it precisely overlays and covers said balloon.
  • the sleeve may be longer than the length of the balloon and arranged such that the balloon is completely covered thereby.
  • the sleeve may be attached to the balloon at one or more discrete attachment points, at any location on the outer surface of the balloon, such that an annular space exists between said sleeve and the catheter shaft on at least one side of said attachment points.
  • a similar annular space may also exist between said sleeve and the outer surface of the balloon on at least one side of said sleeve attachment points.
  • the sleeve may be attached to the balloon at one or more discrete attachment points, at any location on the sleeve surface.
  • the attachment points 76 of the sleeve 78 may, as illustrated in Fig. 10 , be situated close to the proximal end of the balloon 18 ( Fig. 10a ), close to the distal end of said balloon ( Fig. 10b ) or at or close to the mid-point thereof (10c).
  • the other end may optionally be attached to the shaft, distal to the balloon or proximal to the balloon, by mean of at least one sleeve extension, or additional fixing feature including, but not limited to , a hook or a basket, in any suitable form, made of any material, metal or polymer or other.
  • the bonding of the attachment mean to the catheter shaft may be achieved by the use of any suitable biocompatible adhesive, heat welding, ultrasonic welding, or mechanical means.
  • the sleeve may be provided in any suitable form, including (but not limited to) cylindrical, semi-cylindrical, conical, frusto-conical, web-like etc.
  • Said sleeve may be constructed from any suitable biocompatible metal, polymer, other organic material, or of other materials, providing they have the appropriate biomechanical properties. Examples of suitable polymers include those polymers described hereinabove for use in the manufacture of the balloon.
  • Fig. 3 shows insertion of the catheter tip into a small blood vessel 40, for example, to deliver an object 42 into the vessel 40.
  • the object 42 may be, for example, a stent, as shown in Fig. 3 .
  • the object 42 may be a work tool that is to be delivered to be delivered to a site in the body.
  • the work tool may be, for example, a tool for working on a stenosis, such as a drill, dagger, probe, a radioactive source for brachytherapy, etc.
  • the tool may also be, for example, a light guide, a light source, a radio frequency electrode, or an ultrasound probe.
  • the object 42 Prior to insertion of the catheter into the body, the object 42 is mounted onto the distal end of the catheter. In Fig.
  • the catheter tip has been delivered through an artery 44 to the orifice 34 of the vessel 40 with the balloon 18 in its deflated state.
  • the balloon 18 is then inflated so that the inflated balloon is still in its first, proximally located position in which the distal end of the balloon 18 is adjacent to the distal end of the catheter shaft 12, as shown in Fig. 3b .
  • the inflated balloon 18 presses upon the wall of the vessel 44.
  • the catheter tip is then advanced distally into the narrow vessel 40.
  • the balloon 18 also advances in the vessel 44. The balloon 18 thus rolls along the shaft and along the wall of the vessel 44.
  • the speed of the balloon 18 in the vessel 44 is about half of that of the tip of the shaft. Since the balloon 18 advances in the vessel 44 at a slower rate than the catheter shaft 12, the balloon 18 moves posteriorly along the shaft 12 towards the second position of the balloon 18 on the shaft, as shown in Fig. 3c . Further anterior advancement of the catheter tip in the vessel 40 causes the balloon to travel further along the shaft posteriorly, until the catheter tip bearing the stent is completely extended beyond the balloon and the stent is positioned in the vessel 40. Since there is a high level of friction between the outer surface of the balloon with the wall of the vessel, there is no slipping of the outer surface of the balloon on the vessel wall, and there is thus no damage to the vessel wall.
  • the stent can then be deployed in the vessel 40 by any mechanism (not shown) known in the art for deploying a stent.
  • the balloon 18 may be deflated and the catheter withdrawn from the body.
  • Fig. 11A illustrates aspects of a further preferred embodiment in which an expandable stent 42 is mounted over the deflated balloon 18 prior to delivery of the catheter system to the treatment site.
  • This embodiment is of particular value in clinical situations in which it is desired that a single catheter system be used to cause both dilation of a pathologically-involved section of a blood vessel (such as a coronary artery) and to safely retrieve any debris released as a result of the dilatation process (or present in the treated region for any other reason).
  • the same embodiment is shown in Fig. 11B following inflation of the balloon 18 and expansion of the stent 42, after which processes both the stent and the regions of the balloon not covered by the stent are in contact with the internal surface of the wall of the blood vessel 44.
  • the balloon is disposed such that it may be caused to roll along the blood vessel wall (as described hereinabove) thereby trapping debris released during the stenting process between itself and the catheter shaft 12.
  • Fig. 11C One example of this movement of the balloon is shown in Fig. 11C , where the balloon 18 is shown after the catheter shaft 12 has been moved a short distance proximally and the balloon 18 has rolled distally (in relation to said catheter shaft).
  • the balloon may, of course, be caused to roll proximally or, in another preferred mode, it may be caused to alternate between proximal and distal rolling movements, thereby maximizing the debris collection and entrapment.
  • the balloon in this embodiment may also be fitted with a retaining sleeve, as described hereinabove.
  • the catheter shaft used in this embodiment may also be fitted with retentive surface features as described hereinbefore.
  • Fig. 4 shows a catheter 60 which has several components in common with the catheter 10 of Figs. 1 and 2 , and similar components in the catheters 10 and 60 are indicated by the same reference numerals, without further comment or explanation.
  • the catheter 60 includes a ramming mechanism that is used to urge the balloon from its first position shown in Fig. 5a to its second position shown in Fig. 5b .
  • the ramming mechanism includes a cylindrical flexible cover 56 enclosing at least a portion of the catheter shaft 12.
  • the distal end of the flexible cover 56 is attached to an annular ramming plate 57.
  • the cover 56 and the ramming plate 57 are slidable along the catheter shaft 12.
  • Fig. 6 shows use of the catheter 10 for retrieving an object 50 from a body passageway 52.
  • the object 50 may be, for example, a stent that is to be removed from the body.
  • the object 50 may be unwanted debris that is to be removed from the body.
  • the tip of the catheter shaft 12 is advanced in the passageway 52 with the balloon 18 in its deflated state in its first position, until the catheter tip is close to the object 50, with the balloon in its deflated state.
  • the balloon 18 is then inflated ( Fig. 6b ) while remaining in its first position in which the distal end of the balloon 18 is adjacent to the distal end of the catheter tip.
  • the balloon 18 is then urged into its second position by means of the ramming mechanism, as explained above ( Fig. 6c ). As the balloon 18 rolls distally over the catheter tip, the object 50 enters the lumen 54 of the balloon 18, and is grasped by the balloon 18 ( Fig. 6c ). The balloon 18 continues to roll over the catheter tip until it has completely enveloped the object 50 as shown in Fig. 6d . The balloon 18 can then be deflated and the catheter removed from the body together with the object 50.
  • the system of the present invention may also be used to perform a retrograde ballooning procedure for the combined purpose of removing atheromatous plaque materials and preventing the latrogenic release of said materials into the blood streams, as will be presently described.
  • angioplasty is performed by bringing a balloon catheter to the desired operating site, inflating the balloon to a sufficient pressure to allow distension of the arterial wall, thereby expanding and opening the previously blocked or partially-blocked arterial lumen.
  • Such a procedure may be not well adapted to certain pathological situations. For example, vulnerable plaques may present with a very thin cap, prone to rupture thereby releasing their lipid core and atheromatous material downstream into the blood flow.
  • the catheter system of the present invention permits the use of a new therapeutic sodality in which the operator introduces the non-inflated balloon distal to the lesion to be treated.
  • the balloon is then inflated and caused to move proximally with its retrograde, rolling, tank track-like motion by gently pulling the catheter shaft in a proximal direction.
  • the arterial lesion may be squeezed up to its proximal shoulder, allowing release of the lipid core and of the atheromateous material into the blood stream, proximal to the inflated balloon.
  • the operator gently pushes the catheter shaft (i.e, in a distal direction), causing a forward, rolling, tank track-like motion of the balloon along the catheter shaft causing the debris and atheromateous material to be trapped between the catheter shaft and the balloon (or ⁇ if present ⁇ between the retaining sleeve and balloon or within shaft retention elements, as described hereinabove).
  • the operator then deflates the balloon, ensuring complete entrapment of the collected material.
  • the method described hereinabove may also be applied in the opposite direction, i.e. the balloon is inflated on the proximal side of the lesion and then rolled distally.

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EP10169255A 2004-04-22 2005-04-21 Catheter with balloon Expired - Lifetime EP2298192B1 (en)

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IL16155404A IL161554A0 (en) 2004-04-22 2004-04-22 Catheter
EP05735055A EP1753348B1 (en) 2004-04-22 2005-04-21 Catheter with balloon

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Publication number Publication date
IL178738A0 (en) 2007-02-11
US20080051706A1 (en) 2008-02-28
KR20070011526A (ko) 2007-01-24
CA2563657A1 (en) 2005-11-03
CN101972510A (zh) 2011-02-16
US20110040365A1 (en) 2011-02-17
AU2005235226A1 (en) 2005-11-03
US7824370B2 (en) 2010-11-02
EP2298192A1 (en) 2011-03-23
JP2007533394A (ja) 2007-11-22
IL211022A0 (en) 2011-04-28
US8388574B2 (en) 2013-03-05
CN101972510B (zh) 2013-06-12
CN1972636A (zh) 2007-05-30
IL161554A0 (en) 2004-09-27
EP1753348B1 (en) 2010-08-11
WO2005102184A1 (en) 2005-11-03
JP2011200689A (ja) 2011-10-13
ATE476923T1 (de) 2010-08-15
ES2348515T3 (es) 2010-12-07
JP4969441B2 (ja) 2012-07-04
DE602005022858D1 (de) 2010-09-23
CN1972636B (zh) 2010-09-01
EP1753348A1 (en) 2007-02-21

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